Market Fit Evidence

IMPORTANT: This file contains comprehensive evidence of market validation and traction for EPIC-X 2026 application (Section 3: Impact & Market - 25 points). Update placeholders with actual data from Commercial, Finance, Clinical, and Regulatory teams.

Hospital Contracts

Active Hospital Partnerships

Hospital/Client Name	Location	Contract Type	Close Date	Contract Value	Status	Primary Use Case
Bella Aurora	Spain	Consultancy	Sep 14, 2020	EUR 63,555.52	Closed Won	Clinical advisory
SERMAS, Novartis, Hospital Puerta de Hierro	Madrid, Spain	Clinical trial	Jul 16, 2021	EUR 72,000	Closed Won	Clinical trial endpoint
Almirall	Spain	Consultancy	Dec 13, 2021	EUR 20,000	Closed Won	Pharmaceutical partnership
Hospital de Torrejón Pilot	Madrid, Spain	Pilot	Jul 28, 2020	EUR 19,600	Closed Won	Clinical decision support
Sanitas Seguros BluaU	Spain	Integration	Nov 6, 2023	EUR 17,360	Closed Won	Teledermatology platform
[UPDATE: Additional active contracts]	[Country]	[Type]	[Date]	EUR [Amount]	Active	[Use case]
TOTAL WON				EUR 192,515.52	Historical

Notes:

• Contract Types: Subscription (recurring SaaS), License (one-time + maintenance), Clinical Trial (per-study fee)
• Use Cases: Clinical Trials (endpoint assessment), Teledermatology (remote diagnosis support), Clinical Decision Support (in-clinic diagnostic aid)

Hospital Partnership Pipeline (Prospects)

Hospital/Health System	Location	Stage	Expected Close	Projected ARR	Use Case
[UPDATE: Prospect 1]	[City, Country]	[Pilot/Negotiation]	[Quarter Year]	EUR [Amount]	[Use case]
[UPDATE: Prospect 2]	[City, Country]	[Stage]	[Quarter]	EUR [Amount]	[Use case]

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Revenue Metrics

Historical Revenue (Actual)

Year	Total Revenue	YoY Growth	Hospital Contracts (Count)	Clinical Trial Revenue	Other Revenue	Notes
2022	EUR [Amount]	N/A (baseline)	[Count]	EUR [Amount]	EUR [Amount]	[e.g., First commercial year]
2023	EUR [Amount]	[+X%]	[Count]	EUR [Amount]	EUR [Amount]	[e.g., CE marking obtained]
2024	EUR [Amount]	[+X%]	[Count]	EUR [Amount]	EUR [Amount]	[e.g., Hospital expansion]

Revenue Projections (Forecast)

Year	Total Revenue (Projected)	Growth Assumption	Key Drivers
2025	EUR [Amount]	[+X%]	[e.g., US market entry, Germany expansion, 5 new hospital contracts]
2026	EUR [Amount]	[+X%]	[e.g., FDA clearance, Series A funding, 10 new contracts]

Revenue Model: SaaS subscription (recurring) + Clinical trial licensing (project-based)

Customer Retention: [UPDATE: % of customers retained year-over-year, e.g., "95% retention rate"]

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Clinical Validation Studies (7 Studies, 1000+ Patients)

Completed Clinical Studies

Study Code	Study Name/Topic	Hospital/Partner	Location	Patients (n)	Start Date	End Date	Publication Status
BI_2024	Psoriasis APASI Validation	Boehringer Ingelheim (Pharma)	[Location]	1,000	[Month Year]	[Month Year]	Published / In review / Pending
AIHS4_2025	Hidradenitis Suppurativa (HS)	Vall d'Hebron	Barcelona, Spain	[n]	[Start]	[End]	[Status]
SAN_2024	[Study topic]	[Hospital]	[Location]	[n]	[Start]	[End]	[Status]
DAO_2022	Time savings study	[Hospital]	[Location]	[n]	[Start]	[End]	[Status]
IDEI_2023	Eczema validation	[Hospital]	[Location]	[n]	[Start]	[End]	[Status]
MC_EVCDAO_2019	Early validation	[Hospital]	[Location]	[n]	[Start]	[End]	[Status]
[Study 7]	[Topic]	[Hospital]	[Location]	[n]	[Start]	[End]	[Status]
TOTAL		7 studies		1000+			6+ publications

Study Objectives: Clinical validation of AI accuracy, severity assessment validation, clinical workflow impact, time savings quantification

Study Design: Prospective, multi-center, real-world evidence generation

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Peer-Reviewed Publications (6+)

Publications List

#	Authors	Title	Journal	Year	DOI/Link	Citations
1	[UPDATE: Authors]	[UPDATE: Title]	[UPDATE: Journal]	[Year]	[DOI]	[Count]
2	[UPDATE: Authors]	[UPDATE: Title]	[UPDATE: Journal]	[Year]	[DOI]	[Count]
3	[UPDATE: Authors]	[UPDATE: Title]	[UPDATE: Journal]	[Year]	[DOI]	[Count]
4	[UPDATE: Authors]	[UPDATE: Title]	[UPDATE: Journal]	[Year]	[DOI]	[Count]
5	[UPDATE: Authors]	[UPDATE: Title]	[UPDATE: Journal]	[Year]	[DOI]	[Count]
6	[UPDATE: Authors]	[UPDATE: Title]	[UPDATE: Journal]	[Year]	[DOI]	[Count]

Total Citations: [UPDATE: Sum of all citations if available]

Impact: Peer-reviewed publications demonstrate scientific rigor and clinical acceptance of AI technology

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Regulatory Clearances

Obtained Regulatory Approvals

Regulatory Body	Clearance Type	Device Name/Indication	Certificate/Registration #	Clearance Date	Status
CE (EU MDR)	Class IIb Medical Device	Legit.Health Plus (239 ICD-11 conditions)	[UPDATE: Certificate #]	2023	Active
AEMPS (Spain)	Medical Device License	Legit.Health Plus	[UPDATE: License #]	[Year]	Active
MHRA (UK)	Medical Device Registration	Legit.Health Plus	[UPDATE: Registration #]	[Year]	Active
ANVISA (Brazil)	Medical Device Registration	Legit.Health Plus	[UPDATE: Registration #]	[Year]	Active
FDA (US)	Small Business Program	Legit.Health Plus (510(k) ongoing)	N/A	In Progress	Active
ISO 13485:2016	QMS Certification	Quality Management System	[UPDATE: Certificate #]	[Year]	Active

Ongoing Regulatory Submissions

Regulatory Body	Submission Type	Target Indication/Device	Expected Clearance	Status
FDA (US)	510(k)	[UPDATE: Predicate device, indication]	Q[X] 202[X]	[Pre-submission/Submitted]

Regulatory Strategy: High regulatory barrier demonstrates deep-tech credibility and market defensibility

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Clinical Trial Partnerships (Pharmaceutical & CRO)

Active Clinical Trial Collaborations

Pharma/CRO Partner	Trial/Indication	Role of Legit.Health	Contract Value	Duration	Status
Boehringer Ingelheim	Psoriasis (APASI endpoint)	Severity assessment endpoint measurement	EUR [Amount]	[Start]-[End]	Active
Janssen	[UPDATE: Indication]	[UPDATE: Role]	EUR [Amount]	[Dates]	Active
SUN Pharma	[UPDATE: Indication]	[UPDATE: Role]	EUR [Amount]	[Dates]	Active
[Other Partners]	[UPDATE]	[UPDATE]	EUR [Amount]	[Dates]	Active

Total Clinical Trial Revenue (2024): EUR [UPDATE: Total]

Use Cases in Clinical Trials:

• Primary/Secondary Endpoint Assessment: AI-powered severity scoring (PASI, SCORAD, EASI, etc.)
• Patient Screening: Automated eligibility assessment based on lesion classification
• Remote Monitoring: Teledermatology for decentralized trials

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Customer Testimonials

Hospital Dermatologist Testimonials

Testimonial 1 - [Hospital Name], [City, Country]:

"[UPDATE: Quote from dermatologist about diagnostic accuracy, time savings, clinical utility]"

— Dr. [Name], [Title], [Hospital]

Testimonial 2 - [Hospital Name], [City, Country]:

"[UPDATE: Quote about impact on clinical workflow, patient outcomes, or teledermatology use case]"

— Dr. [Name], [Title], [Hospital]

Clinical Trial Manager Testimonials

Testimonial 3 - [Pharma/CRO Name]:

"[UPDATE: Quote about reliability of AI for endpoint assessment, consistency, cost savings]"

— [Name], [Title], [Company]

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Market Opportunity (Addressable Market)

Total Addressable Market (TAM)

Global Dermatology AI Market:

• Market Size (2024): USD $2.3 billion (EUR ~2.1 billion)
• CAGR: 12.5% (2024-2030)
• Market Size (2030): USD $4.7 billion (EUR ~4.3 billion)
• Source: [UPDATE: Market research source, e.g., Mordor Intelligence, IDC, Grand View Research]

Addressable Segments:

• Hospitals: Diagnostic decision support, teledermatology, clinical pathways
• Clinical Trials: Endpoint assessment, patient screening, remote monitoring
• Teledermatology Platforms: B2B integration, white-label solutions

Serviceable Addressable Market (SAM) - Europe + US

European Market:

• Target Countries: Spain, UK, Germany, France, Italy (combined population: ~300M)
• Dermatologists: ~[UPDATE: Count]
• Hospitals with dermatology departments: ~[UPDATE: Count]
• Market opportunity: EUR [UPDATE: Estimated SAM]

US Market:

• Dermatologists: ~[UPDATE: Count]
• Hospitals with dermatology: ~[UPDATE: Count]
• Market opportunity: EUR [UPDATE: Estimated SAM]

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Geographic Expansion Strategy

Current Markets (Established)

Country	Status	Regulatory	Hospital Contracts	Revenue (2024)	Key Partners
Spain	Established	CE MDR	[UPDATE: Count]	EUR [Amount]	[Hospital names]
UK	Established	MHRA	[UPDATE: Count]	EUR [Amount]	[Hospital names]

Target Markets (2025-2026)

Country	Entry Timeline	Regulatory Pathway	Target Contracts (2026)	Projected Revenue (2026)	Key Entry Strategy
Germany	Q2 2025	CE MDR (valid)	3-5 hospitals	EUR [Amount]	[e.g., Partnership with university hospitals]
France	Q3 2025	CE MDR (valid)	2-4 hospitals	EUR [Amount]	[e.g., Focus on AP-HP network]
Italy	Q4 2025	CE MDR (valid)	2-3 hospitals	EUR [Amount]	[e.g., Regional health systems]
USA	Q1 2026	FDA 510(k)	1-2 initial pilots	EUR [Amount]	[e.g., Academic medical centers]

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Next Steps for Data Collection

To complete this file, gather the following from Legit.Health teams:

1. Commercial Team:

   • Hospital contracts: Names, locations, contract types, start dates, annual values, use cases
   • Hospital pipeline: Prospects in negotiation, expected close dates, projected ARR
   • Customer testimonials: 2-3 quotes from dermatologists or clinical trial managers (names, titles, hospitals/companies, permission to use)

2. Finance Team:

   • Historical revenue: 2022, 2023, 2024 actual total revenue
   • Revenue breakdown: Hospital contracts vs. clinical trial licensing vs. other
   • Revenue projections: 2025, 2026 forecasts with growth assumptions
   • Customer retention rate: % of customers retained YoY

3. Clinical Team:

   • Clinical studies: Names/topics, hospitals, locations, patient counts (n), start/end dates, publication status
   • Publications list: 6+ peer-reviewed articles with authors, titles, journals, years, DOIs, citation counts

4. Regulatory Team:

   • Regulatory clearances: Certificate/registration numbers, exact clearance dates, renewal/validity dates
   • FDA 510(k) status: Timeline, predicate device information, expected clearance quarter

5. Commercial/Clinical Teams:

   • Clinical trial partnerships: Pharma/CRO names, indications, roles, contract values, durations, status
   • Total clinical trial revenue (2024)

6. Market Research:

   • TAM/SAM data: Source for EUR 2.3B market size, CAGR, market projections
   • European and US market opportunity estimates (serviceable addressable market)
   • Dermatologist counts, hospital counts by country

7. Strategic Planning:

   • Geographic expansion: Entry timelines, target hospital counts, projected revenue by country for 2026
   • Entry strategies for Germany, France, Italy, USA